510(k) Report

Devices descending from K062759

1,406 later devices reach Paramount VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K173702Juliet Ti LLSpineart20182—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+5K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+5K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+5K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+5K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+5K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+5K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+5K141135Juliet LLSpineart2014146—
+5K141896Coroent SystemNu Vasive, Incorporated2014480—
+5K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+5K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+5K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+5K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+5K1421124WEB Spinal Implant Products4Web, Inc.201433—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+5K132361Everest Spinal SystemK2m, Inc.201334—